BEUDAMED
    8 results · 17ms · Sources: EU EUDAMED, US FDA

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    ACA IMMUNOGLOBULIN A/M CALIBRATORS

    FDA 510(k)
    FDA Class 2 ·Immunology

    A-FIT®

    FDA UDI
    Gc Orthodontics America Inc.·E53581263300001·A-FIT® 1. MOLAR UPR LFT SZ 33

    Disposable Isolation Gown -Level 3, Large, Blue, Disposable Isolation Gown - Level 3, X-Large, Blue

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    RESPIRONICS HEATED HUMIDIFIER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    KC-ARCH-40

    FDA Adverse Event
    Injury ·COOPERSURGICAL, INC.·Product code KOH·May 7, 2014

    RESERVOIR 3ML

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·October 31, 2012

    PRECISION

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·August 17, 2010

    Zeiss brand IOLMaster, Version 1-5, Biomicroscope, Slit-Lamp, AC-Powered, Product is manufactured by Carl Zeiss Meditec AG (Jena), Carl Zeiss Promenade 10, Jena, Germany 07745; and distributed by Carl Zeiss Meditec, Inc., Dublin, CA This device is intended for use primarily by physicians and health care workers and may be only used under the supervision of a physician. This device will not be sold to the general public. The IOLMaster is intended for the biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil. For patients who are candidates for intraocular lens (IOL) implantation, the device also performs calculations to assist physicians in determining the appropriate IOL power and type for implantation

    FDA Enforcement
    Class II ·Terminated·Carl Zeiss Meditec, Inc.·November 27, 2013